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Background: World Health Organization (WHO) developed the Safe Childbirth Checklist as an intervention to improve care and outcomes in maternal and newborn health. In the primary BetterBirth traditional trial analysis, the intervention did not significantly improve . However, a novel subgroup-based analysis could identify subpopulations that benefited from the intervention. Methods: In this work, we employ data-driven analysis methods to identify differentiated subgroups with unexpected characteristics compared to the average population. Specifically, we aim to identify: 1) vulnerable subgroups and 2) subpopulation in the intervention arm with significantly reduced outcome. The method utilizes the existing subset scanning literature that searches over a combination of features to identify the differentiated groups. Findings: We found that low birthweight (

Frequent coaching was associated with increased adherence to evidence-based essential birth practices among birth attendants but not with improved maternal and perinatal health outcomes in the BetterBirth Trial, which assessed the impact of a complex intervention to implement the World Health Organization's Safe Childbirth Checklist. To promote sustainable behavior change, future coaching-based interventions may need to explore cost-effective, feasible mechanisms for providing more frequent coaching delivered with high coverage among health care workers for longer durations., Background: Coaching can improve the quality of care in primary-level birth facilities and promote birth attendant adherence to essential birth practices (EBPs) that reduce maternal and perinatal mortality. The intensity of coaching needed to promote and sustain behavior change is unknown. We investigated the relationship between coaching intensity, EBP adherence, and maternal and perinatal health outcomes using data from the BetterBirth Trial, which assessed the impact of a complex, coaching-based implementation of the World Health Organization's Safe Childbirth Checklist in Uttar Pradesh, India. Methods: For each birth, we defined multiple coaching intensity metrics, including coaching frequency (coaching visits per month), cumulative coaching (total coaching visits accrued during the intervention), and scheduling adherence (coaching delivered as scheduled). We considered coaching delivered at both facility and birth attendant levels. We assessed the association between coaching intensity and birth attendant adherence to 18 EBPs and with maternal and perinatal health outcomes using regression models. Results: Coaching frequency was associated with modestly increased EBP adherence. Delivering 6 coaching visits per month to facilities was associated with adherence to 1.3 additional EBPs (95% confidence interval [CI]=0.6, 1.9). High-frequency coaching delivered with high coverage among birth attendants was associated with greater improvements: providing 70% of birth attendants at a facility with at least 1 visit per month was associated with adherence to 2.0 additional EBPs (95% CI=1.0, 2.9). Neither cumulative coaching nor scheduling adherence was associated with EBP adherence. Coaching was generally not associated with health outcomes, possibly due to the small magnitude of association between coaching and EBP adherence. Conclusions: Frequent coaching may promote behavior change, especially if delivered with high coverage among birth attendants. However, the effects of coaching were modest and did not persist over time, suggesting that future coaching-based interventions should explore providing frequent coaching for longer periods.

IntroductionPreterm birth is the leading cause of child mortality. This study aimed to develop and validate programmatically feasible and accurate approaches to estimate newborn gestational age (GA) in low resource settings.MethodsThe WHO Alliance for Maternal and Newborn Health Improvement (AMANHI) study recruited pregnant women from population-based cohorts in five countries (Bangladesh, Ghana, Pakistan, Tanzania and Zambia). Women Results7428 liveborn infants were included (n=536 preterm, ConclusionThe best machine-learning model (10 neonatal characteristics and LMP) estimated GA within ±15.7 days of early ultrasound dating. Simpler models performed reasonably well with marginal increases in prediction error. These models hold promise for newborn GA estimation when ultrasound dating is unavailable.

Background Accurate assignment of the gestational age of newborns is important for the identification of prematurity. The Dubowitz assessment is the gold standard among postnatal examinations used to assign gestational age, but implementation has been limited because of examination complexity and training requirements. The objective of this study was to explore factors related to teaching and implementing the Dubowitz examination that may influence its uptake in India and Malawi. Methods This cross-sectional study was conducted in India and Malawi during the preparation for a low-birthweight infant feeding exploratory study. Twenty trainees participated in a Dubowitz examination training workshop that occurred over two half-day sessions. Trainees completed pretraining and posttraining surveys related to their perceptions of the Dubowitz training, the examination, and factors affecting the administration of the examination in their setting. Results All survey respondents expressed confidence in their ability to perform the Dubowitz examination after the training. Less than a third expressed concerns about the time required to learn (30%) or perform the examination (25%). Eighty-five percent of trainees identified concerns related to parental perception of the examination that may inhibit implementation. Trainees averaged 14 minutes (standard deviation: 4.5 minutes) to complete the examination. More than 80% of trainee answers were within one point of the trainer for 16 of the 22 Dubowitz signs. Trainee composite scores were within ±3 weeks of the trainer for 95% of assessments based on Bland-Altman analysis. Conclusions The Dubowitz examination at birth is a method to improve identification of premature infants in the absence of prenatal dating. We found widespread acceptance for the Dubowitz assessment among participants in training workshops in India and Malawi, despite the complexity and length of the examination. The high level of trainee-trainer concordance on individual examination signs suggests that an acceptable level of competence is feasible after a short, concentrated workshop. Further investigation into barriers that hinder implementation such as negative parental perceptions is warranted. Registration details Clinical Trials Registration: NCT04002908 (www.clinicaltrials.gov) and CTRI/2019/02/017475 (Clinical Trial Registry of India - http://ctri.nic.in).

OBJECTIVE To understand the prevalence of intrapartum oxytocin use, assess associated perinatal and maternal outcomes, and evaluate the impact of a WHO Safe Childbirth Checklist intervention on oxytocin use at primary-level facilities in Uttar Pradesh, India. DESIGN Secondary analysis of a cluster-randomised controlled trial. SETTING Thirty Primary and Community public health facilities in Uttar Pradesh, India from 2014 to 2017. POPULATION Women admitted to a study facility for childbirth at baseline, 2, 6 or 12 months after intervention initiation. METHODS The BetterBirth intervention aimed to increase adherence to the WHO Safe Childbirth Checklist. We used Rao-Scott Chi-square tests to compare (1) timing of oxytocin use between study arms and (2) perinatal mortality and resuscitation of infants whose mothers received intrapartum oxytocin versus who did not. MAIN OUTCOME MEASURES Intrapartum and postpartum oxytocin administration, perinatal mortality, use of neonatal bag and mask. RESULTS We observed 5484 deliveries. At baseline, intrapartum oxytocin was administered to 78.2% of women. Two months after intervention initiation, intrapartum oxytocin (I) was administered to 32.1% of women compared with 70.6% in the control (C) (P

Background Maternal morbidity occurs several times more frequently than mortality, yet data on morbidity burden and its effect on maternal, foetal, and newborn outcomes are limited in low- and middle-income countries. We aimed to generate prospective, reliable population-based data on the burden of major direct maternal morbidities in the antenatal, intrapartum, and postnatal periods and its association with maternal, foetal, and neonatal death in South Asia and sub-Saharan Africa. Methods and findings This is a prospective cohort study, conducted in 9 research sites in 8 countries of South Asia and sub-Saharan Africa. We conducted population-based surveillance of women of reproductive age (15 to 49 years) to identify pregnancies. Pregnant women who gave consent were include in the study and followed up to birth and 42 days postpartum from 2012 to 2015. We used standard operating procedures, data collection tools, and training to harmonise study implementation across sites. Three home visits during pregnancy and 2 home visits after birth were conducted to collect maternal morbidity information and maternal, foetal, and newborn outcomes. We measured blood pressure and proteinuria to define hypertensive disorders of pregnancy and woman’s self-report to identify obstetric haemorrhage, pregnancy-related infection, and prolonged or obstructed labour. Enrolled women whose pregnancy lasted at least 28 weeks or those who died during pregnancy were included in the analysis. We used meta-analysis to combine site-specific estimates of burden, and regression analysis combining all data from all sites to examine associations between the maternal morbidities and adverse outcomes. Among approximately 735,000 women of reproductive age in the study population, and 133,238 pregnancies during the study period, only 1.6% refused consent. Of these, 114,927 pregnancies had morbidity data collected at least once in both antenatal and in postnatal period, and 114,050 of them were included in the analysis. Overall, 32.7% of included pregnancies had at least one major direct maternal morbidity; South Asia had almost double the burden compared to sub-Saharan Africa (43.9%, 95% CI 27.8% to 60.0% in South Asia; 23.7%, 95% CI 19.8% to 27.6% in sub-Saharan Africa). Antepartum haemorrhage was reported in 2.2% (95% CI 1.5% to 2.9%) pregnancies and severe postpartum in 1.7% (95% CI 1.2% to 2.2%) pregnancies. Preeclampsia or eclampsia was reported in 1.4% (95% CI 0.9% to 2.0%) pregnancies, and gestational hypertension alone was reported in 7.4% (95% CI 4.6% to 10.1%) pregnancies. Prolonged or obstructed labour was reported in about 11.1% (95% CI 5.4% to 16.8%) pregnancies. Clinical features of late third trimester antepartum infection were present in 9.1% (95% CI 5.6% to 12.6%) pregnancies and those of postpartum infection in 8.6% (95% CI 4.4% to 12.8%) pregnancies. There were 187 pregnancy-related deaths per 100,000 births, 27 stillbirths per 1,000 births, and 28 neonatal deaths per 1,000 live births with variation by country and region. Direct maternal morbidities were associated with each of these outcomes. Conclusions Our findings imply that health programmes in sub-Saharan Africa and South Asia must intensify their efforts to identify and treat maternal morbidities, which affected about one-third of all pregnancies and to prevent associated maternal and neonatal deaths and stillbirths. Trial registration The study is not a clinical trial., Author summary Why was this study done? Estimates of severe direct maternal morbidity are largely based on hospital-based studies with inconsistent definitions and varying selection criteria. Limited data are available from South Asia and sub-Saharan Africa, the 2 regions with the highest maternal and newborn morbidity and mortality, where a larger proportion of births occur at home. What did the researchers do and find? We collected data on maternal morbidities from a cohort of women in the community in multiple sites in sub-Saharan Africa and in South Asia. Out of a cohort of >114,000 women, we found that about 1 in 3 women suffer a maternal morbidity, which was notably higher than the previously reported data. We found that the prevalence of preeclampsia and eclampsia was about 1%, which was lower than previously reported. About 11% of women reported having prolonged or obstructed labour, which was somewhat higher than published estimates. The burden of pregnancy-related infection in postpartum period was higher in South Asia than in sub-Saharan Africa. This is the first study, to our knowledge, to describe the burden of antepartum haemorrhage and late antepartum infection and to clearly demonstrate the association of direct maternal morbidity with adverse pregnancy outcomes. What do these findings mean? Higher burden of direct maternal morbidity and its association with adverse outcomes highlights the need for improving health of women and mothers, including promotion of preconception health and nutrition, and high-quality antepartum, intrapartum and postpartum care.

Objective Omphalitis, or umbilical cord infection, is an important cause of newborn morbidity and mortality in low-resource settings. We tested an algorithm that task-shifts omphalitis diagnosis to community-level workers in sub-Saharan Africa. Methods Community-based field monitors and Zambian paediatricians independently evaluated newborns presenting to health facilities in Southern Zambia using a signs and symptoms checklist. Responses were compared against the paediatrician's gold standard clinical diagnosis. Results Of 1009 newborns enrolled, 6.2% presented with omphalitis per the gold standard clinical diagnosis. Paediatricians' signs and symptoms with the highest sensitivity were presence of pus (79.4%), redness at the base (50.8%) and newborn flinching when cord was palpated (33.3%). The field monitor's signs and symptoms answers had low correlation with paediatrician's answers; all signs and symptoms assessed had sensitivity Conclusion Despite extensive training, field monitors could not consistently identify signs and symptoms associated with omphalitis in the sub-Saharan African setting.

Background Adherence to evidence-based essential birth practices is critical for improving health outcomes for mothers and newborns. The WHO Safe Childbirth Checklist (SCC) incorporates these practices, which occur during 4 critical pause points: on admission, before pushing (or cesarean delivery), soon after birth, and before discharge. A peer-coaching strategy to support consistent use of the SCC may be an effective approach to increase birth attendants' adherence to these practices. Methods We assessed data from 60 public health facilities in Uttar Pradesh, India, that received an 8-month staggered coaching intervention from December 2014 to September 2016 as part of the BetterBirth Trial, which is studying effectiveness of an SCC-centered intervention on maternal and neonatal harm. Nurse coaches recorded birth attendants' adherence to 39 essential birth practices. Practice adherence was calculated for each intervention month. After 2 months of coaching, a subsample of 15 facilities was selected for independent observation when the coach was not present. We compared adherence to the 18 practices recorded by both coaches and independent observers. Results Coaches observed birth attendants' behavior during 5,971 deliveries. By the final month of the intervention, 35 of 39 essential birth practices had achieved >90% adherence in the presence of a coach, compared with only 7 of 39 practices during the first month. Key behaviors with the greatest improvement included explanation of danger signs, temperature measurement, assessment of fetal heart sounds, initiation of skin-to-skin contact, and breastfeeding. Without a coach present, birth attendants' average adherence to practices and checklist use was 24 percentage points lower than when a coach was present (range: -1% to 62%). Conclusion Implementation of the WHO Safe Childbirth Checklist with coaching improved uptake of and adherence to essential birth practices. Coordination and communication among facility staff, as well as behaviors with an immediate, tangible benefit, showed the greatest improvement. Difficult-to-perform behaviors and those with delayed or theoretical benefits were less likely to be sustained without a coach present. Coaching may be an important component in implementing the Safe Childbirth Checklist at scale.Note: At the time of publication of this article, the results of evaluation of the impact of the BetterBirth intervention were pending publication in another journal. After the impact findings have been published, we will update this article on the effect of the intervention on birth practices with a reference to the impact findings.

Background: Chlorhexidine umbilical cord washes reduce neonatal mortality in south Asian populations with high neonatal mortality rates and predominantly home-based deliveries. No data exist for sub-Saharan African populations with lower neonatal mortality rates or mostly facility-based deliveries. We compared the effect of chlorhexidine with dry cord care on neonatal mortality rates in Zambia. Methods: We undertook a cluster-randomised controlled trial in Southern Province, Zambia, with 90 health facility-based clusters. We enrolled women who were in their second or third trimester of pregnancy, aged at least 15 years, and who would remain in the catchment area for follow-up of 28 days post-partum. Newborn babies received clean dry cord care (control) or topical application of 10 mL of a 4% chlorhexidine solution once per day until 3 days after cord drop (intervention), according to cluster assignment. We used stratified, restricted randomisation to divide clusters into urban or two rural groups (located

Background In 2014, Vietnam was the first Southeast Asian country to commit to achieving the World Health Organization’s 90–90-90 global HIV targets (90% know their HIV status, 90% on sustained treatment, and 90% virally suppressed) by 2020. This pledge represented further confirmation of Vietnam’s efforts to respond to the HIV epidemic, one feature of which has been close collaboration with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). Starting in 2004, PEPFAR supported community outreach programs targeting high-risk populations (people who inject drugs, men who have sex with men, and sex workers). To provide early evidence on program impact, in 2007–2008 we conducted a nationwide evaluation of PEPFAR-supported outreach programs in Vietnam. The evaluation focused on assessing program effect on HIV knowledge, high-risk behaviors, and HIV testing among high-risk populations—results relevant to Vietnam’s push to meet global HIV goals. Methods We used a mixed-methods cross-sectional evaluation design. Data collection encompassed a quantitative survey of 2199 individuals, supplemented by 125 in-depth interviews. Participants were members of high-risk populations who reported recent contact with an outreach worker (intervention group) or no recent contact (comparison group). We assessed differences in HIV knowledge, risky behaviors, and HIV testing between groups, and between high-risk populations. Results Intervention participants knew significantly more about transmission, prevention, and treatment than comparison participants. We found low levels of injection drug-use-related risk behaviors and little evidence of program impact on such behaviors. In contrast, a significantly smaller proportion of intervention than comparison participants reported risky sexual behaviors generally and within each high-risk population. Intervention participants were also more likely to have undergone HIV testing (76.1% vs. 47.0%, p

Background The BetterBirth trial tested the effect of a peer coaching program around the WHO Safe Childbirth Checklist for birth attendants in primary-level facilities in Uttar Pradesh, India on a composite measure of perinatal and maternal mortality and maternal morbidity. This study aimed to examine the adherence to essential birth practices between two different cadres of birth attendants—nurses and auxiliary nurse midwives (ANMs)—during and after a peer coaching intervention for the WHO Safe Childbirth Checklist. Methods This is a secondary analysis of birth attendant characteristics, coaching visits, and behavior uptake during the BetterBirth trial through birth attendant surveys, coach observations, and independent observations. Descriptive statistics were calculated overall, and by staffing cadre (staff nurses and ANMs) for demographic characteristics. Logistic regression using the Pearson overdispersion correction (to account for clustering by site) was used to assess differences between staff nurses and ANMs in the intervention group during regular coaching (2-month time point) and 4 months after the coaching program ended (12-month time point). Results Of the 570 birth attendants who responded to the survey in intervention and control arms, 474 were staff nurses (83.2%) and 96 were ANMs (16.8%). In the intervention arm, more staff nurses (240/260, 92.3%) received coaching at all pause points compared to ANMs (40/53, 75.5%). At baseline, adherence to practices was similar between ANMs and staff nurses (~ 30%). Overall percent adherence to essential birth practices among ANMs and nurses was highest at 2 months after intervention initiation, when frequent coaching visits occurred (68.1% and 64.1%, respectively, p = 0.76). Practice adherence tapered to 49.2% among ANMs and 56.1% among staff nurses at 12 months, which was 4 months after coaching had ended (p = 0.68). Conclusions Overall, ANMs and nurses responded similarly to the coaching intervention with the greatest increase in percent adherence to essential birth practices after 2 months of coaching and subsequent decrease in adherence 4 months after coaching ended. While coaching is an effective strategy to support some aspects of birth attendant competency, the structure, content, and frequency of coaching may need to be customized according to the birth attendant training and competency. Trial registration ClinicalTrials.gov: NCT2148952; Universal Trial Number: U1111–1131-5647.

BACKGROUND Early initiation of combination antiretroviral therapy (cART) for HIV-positive pregnant women can decrease vertical transmission to less than 5%. Programmatic barriers to early cART include decentralized care, disease-stage assessment delays, and loss to follow-up. INTERVENTION Our intervention had 3 components: integrated HIV and antenatal services in 1 location with 1 provider, laboratory courier to expedite CD4 counts, and community-based follow-up of women-infant pairs to improve prevention of mother-to-child transmission attendance. Preintervention HIV-positive pregnant women were referred to HIV clinics for disease-stage assessment and cART initiation for advanced disease (CD4 count 2). METHODS We used a quasi-experimental design with preintervention/postintervention evaluations at 6 government antenatal clinics (ANCs) in Southern Province, Zambia. Retrospective clinical data were collected from clinic registers during a 7-month baseline period. Postintervention data were collected from all antiretroviral therapy-naive, HIV-positive pregnant women and their infants presenting to ANC from December 2011 to June 2013. RESULTS Data from 510 baseline women-infant pairs were analyzed and 624 pregnant women were enrolled during the intervention period. The proportion of HIV-positive pregnant women receiving CD4 counts increased from 50.6% to 77.2% [relative risk (RR) = 1.81; 95% confidence interval (CI): 1.57 to 2.08; P < 0.01]. The proportion of cART-eligible pregnant women initiated on cART increased from 27.5% to 71.5% (RR = 2.25; 95% CI: 1.78 to 2.83; P < 0.01). The proportion of eligible HIV-exposed infants with documented 6-week HIV PCR test increased from 41.9% to 55.8% (RR = 1.33; 95% CI: 1.18 to 1.51; P < 0.01). CONCLUSIONS Integration of HIV care into ANC and community-based support improved uptake of CD4 counts, proportion of cART-eligible women initiated on cART, and infants tested.

Background: Research demonstrates that coaching is an effective method for promoting behavior change, yet little is known about which attributes of a coach make them more or less effective. This post hoc, sub-analysis of the BetterBirth trial used observational data to explore whether specific coaches’ and team leaders' characteristics were associated with improved adherence to essential birth practices listed on the World Health Organization Safe Childbirth Checklist. Methods: A descriptive analysis was conducted on the coach characteristics from the 50 BetterBirth coaches and team leaders. Data on adherence to essential birth practices by birth attendants who received coaching were collected by independent observers. Bivariate linear regression models were constructed, accounting for clustering by site, to examine the association between coach characteristics and attendants’ adherence to practices. Results: All of the coaches were female and the majority were nurses. Team leaders were comprised of both males and females; half had clinical backgrounds. There was no association between coaches’ or team leaders’ characteristics, namely gender, type of degree, or years of clinical training, and attendants’ adherence to essential birth practices. However, a significant inverse relationship was detected between the coach or team leader’s age and years of experience and the birth attendants’ adherence to the checklist. Conclusion: Younger, less experienced coaches were more successful in promoting essential birth practices adherence in this population. More data is needed to fully understand the relationship between coaches and birth attendants.

OBJECTIVE: The objective of the Alliance for Maternal and Newborn Health Improvement (AMANHI) gestational age study is to develop and validate a programmatically feasible and simple approach to accurately assess gestational age of babies after they are born. The study will provide accurate, population-based rates of preterm birth in different settings and quantify the risks of neonatal mortality and morbidity by gestational age and birth weight in five South Asian and sub-Saharan African sites. METHODS: This study used on-going population-based cohort studies to recruit pregnant women early in pregnancy (

Shifting childbirth into facilities has not improved health outcomes for mothers and newborns as significantly as hoped. Improving the quality and safety of care provided during facility-based childbirth requires helping providers to adhere to essential birth practices—evidence-based behaviors that reduce harm to and save lives of mothers and newborns. To achieve this goal, we developed the BetterBirth Program, which we tested in a matched-pair, cluster-randomized controlled trial in Uttar Pradesh, India. The goal of this intervention was to improve adoption and sustained use of the World Health Organization Safe Childbirth Checklist (SCC), an organized collection of 28 essential birth practices that are known to improve the quality of facility-based childbirth care. Here, we describe the BetterBirth Program in detail, including its 4 main features: implementation tools, an implementation strategy of coaching, an implementation pathway (Engage-Launch-Support), and a sustainability plan. This coaching-based implementation of the SCC motivates and empowers care providers to identify, understand, and resolve the barriers they face in using the SCC with the resources already available. We describe important lessons learned from our experience with the BetterBirth Program as it was tested in the BetterBirth Trial. For example, the emphasis on relationship building and respect led to trust between coaches and birth attendants and helped influence change. In addition, the cloud-based data collection and feedback system proved a valuable asset in the coaching process. More research on coaching-based interventions is required to refine our understanding of what works best to improve quality and safety of care in various settings. (After publication of this article, the impact results of the BetterBirth intervention were published in the New England Journal of Medicine [volume 377, pages 2313-2324, doi: 10.1056/NEJMoa1701075]. The results showed that the intervention had no significant effect on maternal or perinatal mortality or maternal morbidity, despite having positive effects on essential birth practices.)

INTRODUCTION: Access to lifesaving prevention of mother-to-child transmission (PMTCT) services is problematic in rural Zambia. The simplest intervention used in Zambia has been 2-dose nevirapine (NVP) administration in the peripartum period a regimen of 1 NVP tablet to the mother at the onset of labor and 1 dose in the form of syrup to the newborn within 4 to 72 hours after birth. This 2-dose regimen has been shown to reduce MTCT by nearly 50%. We set out to demonstrate that in-home HIV testing and NVP dosing by traditional birth attendants (TBAs) is feasible and acceptable by women in rural Zambia. METHODS: This was a pilot program using TBAs to perform rapid saliva-based HIV testing and administer single-dose NVP in tablet form to the mother at the onset of labor and syrup to the infant after birth. RESULTS: A total of 280 pregnant women were consented and enrolled into the program of whom 124 (44.3%) gave birth at home with the assistance of a trained TBA. Of those 16 (12.9%) were known to be HIV positive and 101 of the remaining 108 (93.5%) accepted a rapid HIV test. All these women tested HIV negative. In the subset of 16 mothers who were HIV positive 13 (81.3%) took single-dose NVP administered by a TBA between 1 and 24 hours prior to birth and 100% of exposed newborns (16 of 16) received NVP syrup within 72 hours after birth 80% of whom were dosed in the first 24 hours of life. DISCUSSION: With the substantial shortage of human resources in public health care throughout sub-Saharan Africa it is extremely valuable to utilize lay health care workers to help extended services beyond the level of the facility. Given the high uptake of PMTCT services we believe that TBAs with proper training and support can successfully provide country-approved PMTCT. (c) 2013 by the American College of Nurse-Midwives.

To estimate neonatal mortality, particularly within 24 hours of birth, in six low- and lower-middle-income countries.We analysed epidemiological data on a total of 149 570 live births collected between 2007 and 2013 in six prospective randomized trials and a cohort study from predominantly rural areas of Bangladesh, Ghana, India, Pakistan, the United Republic of Tanzania and Zambia. The neonatal mortality rate and mortality within 24 hours of birth were estimated for all countries and mortality within 6 hours was estimated for four countries with available data. The findings were compared with published model-based estimates of neonatal mortality.Overall, the neonatal mortality rate observed at study sites in the six countries was 30.5 per 1000 live births (range: 13.6 in Zambia to 47.4 in Pakistan). Mortality within 24 hours was 14.1 per 1000 live births overall (range: 5.1 in Zambia to 20.1 in India) and 46.3% of all neonatal deaths occurred within 24 hours (range: 36.2% in Pakistan to 65.5% in the United Republic of Tanzania). Mortality in the first 6 hours was 8.3 per 1000 live births, i.e. 31.9% of neonatal mortality.Neonatal mortality within 24 hours of birth in predominantly rural areas of six low- and lower-middle-income countries was higher than model-based estimates for these countries. A little under half of all neonatal deaths occurred within 24 hours of birth and around one third occurred within 6 hours. Implementation of high-quality, effective obstetric and early newborn care should be a priority in these settings.Estimer la mortalité néonatale, en particulier dans les 24 heures suivant la naissance, dans six pays à revenu faible et intermédiaire - tranche inférieure.Nous avons analysé des données épidémiologiques portant sur un total de 149 570 naissances vivantes qui avaient été recueillies entre 2007 et 2013 lors de six essais prospectifs randomisés et d'une étude de cohorte réalisés dans des zones majoritairement rurales du Bangladesh, du Ghana, d'Inde, du Pakistan, de Tanzanie et de Zambie. Le taux de mortalité néonatale ainsi que la mortalité dans les 24 heures suivant la naissance ont été estimés pour tous ces pays; la mortalité dans les 6 heures suivant la naissance a été estimée pour quatre pays sur lesquels nous avions des données. Les résultats ont été comparés aux estimations de la mortalité néonatale publiées, qui ont été établies d'après des modèles.Globalement, le taux de mortalité néonatale observé sur les sites étudiés dans les six pays était de 30,5 pour 1000 naissances vivantes (de 13,6 en Zambie à 47,4 au Pakistan). La mortalité globale dans les 24 heures suivant la naissance était de 14,1 pour 1000 naissances vivantes (de 5,1 en Zambie à 20,1 en Inde) et 46,3% de l'ensemble des décès néonataux étaient survenus dans les 24 heures (de 36,2% au Pakistan à 65,5% en Tanzanie). Le taux de mortalité dans les 6 heures suivant la naissance était de 8,3 pour 1000 naissances vivantes, soit 31,9% de la mortalité néonatale totale.La mortalité néonatale dans les 24 heures suivant la naissance dans des zones majoritairement rurales de six pays à revenu faible et intermédiaire-tranche inférieure était supérieure aux estimations établies d'après des modèles pour ces pays. Un peu moins de la moitié des décès néonataux étaient survenus dans les 24 heures suivant la naissance et environ un tiers dans les 6 heures. La mise en place de soins obstétriques et néonataux efficaces et de haute qualité devrait être une priorité dans ces pays.Calcular la mortalidad neonatal, especialmente durante las 24 horas posteriores al nacimiento, en países con ingresos bajos y países con ingresos medios más bajos.Se analizaron datos epidemiológicos de un total de 149 570 nacidos vivos recopilados entre 2007 y 2013 en seis ensayos aleatorizados prospectivos y un estudio de cohortes de zonas principalmente rurales de Bangladesh, Ghana, India, Pakistán, la República Unida de Tanzanía y Zambia. Se calculó la tasa de mortalidad neonatal y la mortalidad durante las 24 horas posteriores al nacimiento en todos los países y se estimó la tasa de mortalidad en 6 horas en cuatro países con información disponible. Los resultados se compararon con estimaciones publicadas basadas en modelos de mortalidad neonatal.En general, la tasa de mortalidad neonatal observada en los lugares de estudio de los seis países fue de 30,5 por cada 1 000 nacidos vivos (alcance: 13,6 en Zambia a 47,4 en Pakistán). En conjunto, la mortalidad durante las primeras 24 horas fue de 14,1 por cada 1 000 nacidos vivos (alcance: 5,1 en Zambia a 20,1 en India) y el 46,3% de todas las muertes neonatales se produjo durante las primeras 24 horas (alcance: 36,2% en Pakistán a 65,5% en la República Unida de Tanzanía). La mortalidad en las primeras 6 horas fue de 8,3 por cada 1 000 nacidos vivos, es decir, un 31,9% de mortalidad neonatal.La mortalidad neonatal durante las 24 horas posteriores al nacimiento en zonas principalmente rurales de seis países con ingresos bajos y países con ingresos medios más bajos fue superior a las estimaciones basadas en modelos realizadas para estos países. Algo menos de la mitad de todas las muertes neonatales se produjeron durante las 24 horas posteriores al nacimiento y cerca de un tercio durante las primeras 6 horas de vida. En estos lugares, la implementación de obstetricia eficaz y de alta calidad y la atención a recién nacidos debería ser una prioridad.تقدير معدل وفيات الأطفال حديثي الولادة، وبالأخص في غضون 24قمنا بتحليل البيانات الوبائية لإجمالي 149,570عمومًا، كان معدل وفيات الأطفال حديثي الولادة الذي لوحظ في مواقع الدراسة في ستة بلدان يبلغ 30.5 لكل 1000 من المواليد على قيد الحياة (نطاق القياس: 13.6 في زامبيا إلى 47.4إن معدل الوفيات للأطفال حديثي الولادة في غضون 24旨在评估 6 个中低收入国家的新生儿死亡率、尤其是出生后 24 小时内的死亡率。.我们一共对 149 570 名新出生婴儿的流行病学数据进行了分析，该数据来自于 2007 年至 2013 年对巴基斯坦、印度、加纳、孟加拉国、坦桑尼亚联合共和国及赞比亚主要乡村地区进行的 6 项前瞻性随机试验和一项队列研究。 我们对所有国家的新生儿死亡率以及新生儿出生后 24 小时内的死亡率进行了评估，并对拥有可用数据的 4 个国家的新生儿出生后 6 小时内的死亡率进行了评估。 我们将调查结果与已发布的、基于模型的新生儿死亡率估算结果进行了比较。.总体而言， 6 个国家的研究地的实际新生儿死亡率为每 1000 名新出生婴儿中有 30.5 名死亡（范围： 从赞比亚的 13.6 到巴基斯坦的 47.4）。 新生儿出生后 24 小时内死亡率为每 1000 名新出生婴儿中共有 14.1 名死亡（范围： 从赞比亚的 5.1 到印度的 20.1），且 46.3% 的新生儿死亡案例发生在婴儿出生后 24 小时内（范围： 从巴基斯坦的 36.2% 到坦桑尼亚联合共和国的 65.5%）。 婴儿出生后 6 小时内的死亡率为每 1000 名新出生婴儿中有 8.3 名死亡，即新生儿死亡率为 31.9%。.6 个中低收入国家主要乡村地区的新生儿出生后 24 小时内的死亡率均高于这些国家的基于模型的估算结果。 略低于一半的新生儿死亡案例发生在婴儿出生后 24 小时内，而大约三分之一的案例发生在婴儿出生后 6 小时内。 上述国家应将实施优质、有效的产科护理和早期新生儿护理视为工作重点。.Дать оценку смертности новорожденных, особенно в первые 24 часа жизни, в шести странах с низким уровнем дохода и уровнем дохода ниже среднего.Проведен анализ эпидемиологических данных, полученных в результате рождения 149 570 живых детей в промежутке с 2007 по 2013 год, на основании шести проспективных рандомизированных исследований и одного когортного исследования в преимущественно сельских регионах Бангладеша, Ганы, Замбии, Индии, Объединенной Республики Танзании и Пакистана. Были рассчитаны показатели смертности новорожденных в первые 24 часа для всех стран, а оценка смертности в первые шесть часов была получена для четырех стран с доступными данными. Результаты сравнили с опубликованными показателями смертности новорожденных, рассчитанными на основе моделирования.В целом показатель смертности новорожденных, наблюдаемый в центрах проведения исследования шести стран, составил 30,5 на 1000 рождений живых детей (от 13,6 в Замбии до 47,4 в Пакистане). Смертность в течение первых суток в целом составляла 14,1 на 1000 рождений живых детей (диапазон: от 5,1 в Замбии до 20,1 в Индии) или 46,3% от всех смертей новорожденных (от 36,2% в Пакистане до 65,5% в Объединенной Республике Танзания). Смертность в первые шесть часов составляла 8,3 на 1000 рождений живых детей или 31,9% от всех смертей новорожденных.Смертность новорожденных в первые 24 часа в преимущественно сельских регионах шести стран с низким уровнем дохода и уровнем дохода ниже среднего была выше, чем показатели, рассчитанные на основе моделирования для этих же стран. Чуть менее половины всех смертей новорожденных произошли в течение 24 часов после рождения, и около трети произошли в течение первых шести часов. Поэтому внедрение высококачественной эффективной акушерской помощи и ухода за новорожденными должно стать первостепенной задачей.

Background Effective, scalable strategies to improve maternal, fetal, and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries. Building on the successes of previous checklist-based programs, the World Health Organization (WHO) and partners led the development of the Safe Childbirth Checklist (SCC), a 28-item list of evidence-based practices linked with improved maternal and newborn outcomes. Pilot-testing of the Checklist in Southern India demonstrated dramatic improvements in adherence by health workers to essential childbirth-related practices (EBPs). The BetterBirth Trial seeks to measure the effectiveness of SCC impact on EBPs, deaths, and complications at a larger scale. Methods/design This matched-pair, cluster-randomized controlled, adaptive trial will be conducted in 120 facilities across 24 districts in Uttar Pradesh, India. Study sites, identified according to predefined eligibility criteria, were matched by measured covariates before randomization. The intervention, the SCC embedded in a quality improvement program, consists of leadership engagement, a 2-day educational launch of the SCC, and support through placement of a trained peer “coach” to provide supportive supervision and real-time data feedback over an 8-month period with decreasing intensity. A facility-based childbirth quality coordinator is trained and supported to drive sustained behavior change after the BetterBirth team leaves the facility. Study participants are birth attendants and women and their newborns who present to the study facilities for childbirth at 60 intervention and 60 control sites. The primary outcome is a composite measure including maternal death, maternal severe morbidity, stillbirth, and newborn death, occurring within 7 days after birth. The sample size (n = 171,964) was calculated to detect a 15% reduction in the primary outcome. Adherence by health workers to EBPs will be measured in a subset of births (n = 6000). The trial will be conducted in close collaboration with key partners including the Governments of India and Uttar Pradesh, the World Health Organization, an expert Scientific Advisory Committee, an experienced local implementing organization (Population Services International, PSI), and frontline facility leaders and workers. Discussion If effective, the WHO Safe Childbirth Checklist program could be a powerful health facility-strengthening intervention to improve quality of care and reduce preventable harm to women and newborns, with millions of potential beneficiaries. Trial registration BetterBirth Study Protocol dated: 13 February 2014; ClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1673-x) contains supplementary material, which is available to authorized users.

Objective To see if, in the diagnosis of infant infection with human immunodeficiency virus (HIV) in Zambia, turnaround times could be reduced by using an automated notification system based on mobile phone texting. Methods In Zambia’s Southern province, dried samples of blood from infants are sent to regional laboratories to be tested for HIV with polymerase chain reaction (PCR). Turnaround times for the postal notification of the results of such tests to 10 health facilities over 19 months were evaluated by retrospective data collection. These baseline data were used to determine how turnaround times were affected by customized software built to deliver the test results automatically and directly from the processing laboratory to the health facility of sample origin via short message service (SMS) texts. SMS system data were collected over a 7.5-month period for all infant dried blood samples used for HIV testing in the 10 study facilities. Findings Mean turnaround time for result notification to a health facility fell from 44.2 da ys pre-implementation to 26.7 da ys postimplementation. The reduction in turnaround time was statistically significant in nine (90%) facilities. The mean time to notification of a caregiver also fell significantly, from 66.8 da ys pre-implementation to 35.0 da ys post-implementation. Only 0.5% of the texted reports investigated differed from the corresponding paper reports. Conclusion The texting of the results of infant HIV tests significantly shortened the times between sample collection and results notification to the relevant health facilities and caregivers.

Background: Reducing maternal and neonatal mortality is essential to improving population health. Demand-side interventions are designed to increase uptake of critical maternal health services, but associated change in service uptake and outcomes is varied. We undertook a literature review to understand current evidence of demand-side intervention impact on improving utilization and outcomes for mothers and newborn children. Methods: We completed a rapid review of literature in PubMed. Title and abstracts of publications identified from selected search terms were reviewed to identify articles meeting inclusion criteria: demand-side intervention in low or middle-income countries (LMIC), published after September 2004 and before March 2014, study design describing and reporting on >1 priority outcome: utilization (antenatal care visits, facility-based delivery, delivery with a skilled birth attendant) or health outcome measures (maternal mortality ratio (MMR), stillbirth rate, perinatal mortality rate (PMR), neonatal mortality rate (NMR)). Bibliographies were searched to identify additional relevant papers. Articles were abstracted using a standardized data collection template with double extraction on a sample to ensure quality. Quality of included studies was assessed using McMaster University’s Quality Assessment Tool from the Effective Public Health Practice Project (EPHPP). Results: Five hundred and eighty two articles were screened with 50 selected for full review and 16 meeting extraction criteria (eight community mobilization interventions (CM), seven financial incentive interventions (FI), and one with both). We found that demand-side interventions were effective in increasing uptake of key services with five CM and all seven FI interventions reporting increased use of maternal health services. Association with health outcome measures were varied with two studies reporting reductions in MMR and four reporting reduced NMR. No studies found a reduction in stillbirth rate. Only four of the ten studies reporting on both utilization and outcomes reported improvement in both measures. Conclusions: We found strong evidence that demand-side interventions are associated with increased utilization of services with more variable evidence of their impact on reducing early neonatal and maternal mortality. Further research is needed to understand how to maximize the potential of demand-side interventions to improve maternal and neonatal health outcomes including the role of quality improvement and coordination with supply-side interventions.

Implementation of the WHO Safe Childbirth Checklist with peer coaching resulted in >90% adherence to 35 of 39 essential birth practices among birth attendants after 8 months, but adherence to some practices was lower when the coach was absent., Background: Adherence to evidence-based essential birth practices is critical for improving health outcomes for mothers and newborns. The WHO Safe Childbirth Checklist (SCC) incorporates these practices, which occur during 4 critical pause points: on admission, before pushing (or cesarean delivery), soon after birth, and before discharge. A peer-coaching strategy to support consistent use of the SCC may be an effective approach to increase birth attendants' adherence to these practices. Methods: We assessed data from 60 public health facilities in Uttar Pradesh, India, that received an 8-month staggered coaching intervention from December 2014 to September 2016 as part of the BetterBirth Trial, which is studying effectiveness of an SCC-centered intervention on maternal and neonatal harm. Nurse coaches recorded birth attendants' adherence to 39 essential birth practices. Practice adherence was calculated for each intervention month. After 2 months of coaching, a subsample of 15 facilities was selected for independent observation when the coach was not present. We compared adherence to the 18 practices recorded by both coaches and independent observers. Results: Coaches observed birth attendants' behavior during 5,971 deliveries. By the final month of the intervention, 35 of 39 essential birth practices had achieved >90% adherence in the presence of a coach, compared with only 7 of 39 practices during the first month. Key behaviors with the greatest improvement included explanation of danger signs, temperature measurement, assessment of fetal heart sounds, initiation of skin-to-skin contact, and breastfeeding. Without a coach present, birth attendants' average adherence to practices and checklist use was 24 percentage points lower than when a coach was present (range: −1% to 62%). Conclusion: Implementation of the WHO Safe Childbirth Checklist with coaching improved uptake of and adherence to essential birth practices. Coordination and communication among facility staff, as well as behaviors with an immediate, tangible benefit, showed the greatest improvement. Difficult-to-perform behaviors and those with delayed or theoretical benefits were less likely to be sustained without a coach present. Coaching may be an important component in implementing the Safe Childbirth Checklist at scale. (After publication of this article, the impact results of the BetterBirth intervention were published in the New England Journal of Medicine [volume 377, pages 2313-2324, doi: 10.1056/NEJMoa1701075]. The results showed that the intervention had no significant effect on maternal or perinatal mortality or maternal morbidity, despite having positive effects on essential birth practices.)

BACKGROUND: Early weaning has been recommended to reduce postnatal human immunodeficiency virus (HIV) transmission. We evaluated the safety of stopping breast-feeding at different ages for mortality of uninfected children born to HIV-infected mothers. METHODS: During a trial of early weaning 958 HIV-infected mothers and their infants were recruited and followed up from birth to 24 months postpartum in Lusaka Zambia. One-half of the cohort was randomized to wean abruptly at 4 months and the other half of the cohort was randomized to continue breast-feeding. We examined associations between uninfected child mortality and actual breast-feeding duration and investigated possible confounding and effect modification. RESULTS: The mortality rate among 749 uninfected children was 9.4% by 12 months of age and 13.6% by 24 months of age. Weaning during the interval encouraged by the protocol (4-5 months of age) was associated with a 2.03-fold increased risk of mortality (95% confidence interval [CI] 1.13-3.65) weaning at 6-11 months of age was associated with a 3.54-fold increase (95% CI 1.68-7.46) and weaning at 12-18 months of age was associated with a 4.22-fold increase (95% CI 1.59-11.24). Significant effect modification was detected such that risks associated with weaning were stronger among infants born to mothers with higher CD4(+) cell counts (>350 cells/microL). CONCLUSION: Shortening the normal duration of breast-feeding for uninfected children born to HIV-infected mothers living in low-resource settings is associated with significant increases in mortality extending into the second year of life. Intensive nutritional and counseling interventions reduce but do not eliminate this excess mortality.

OBJECTIVES: Single-dose nevirapine (SDNVP) for prevention of mother-to-child HIV transmission selects mutations conferring resistance to nonnucleoside reverse transcriptase inhibitor (NNRTI)-based therapy. We investigated mortality and virologic and clinical outcomes after introduction of antiretroviral treatment (ART) among a cohort of women given SDNVP. METHODS: When ART programs were introduced in 2004 in Lusaka Zambia we were completing a trial of infant feeding which involved following HIV-infected women who received SDNVP between 2001 and 2005. Women still in follow-up or who could be contacted were evaluated for eligibility for ART (CD4 count or=3) and started on NNRTI-based therapy if eligible. We compared mortality in the cohort of women before and after ART access and examined among women initiating ART whether virologic response was better allowing a longer time to elapse between SDNVP and treatment initiation. RESULTS: In the cohort of 872 women mortality more than halved after ART became available (relative hazard = 0.46 95% confidence interval: 0.23 to 0.91 P = 0.03). Of 161 SDNVP-exposed women followed on NNRTI-based ART 70.8% suppressed (viral load 24 months after exposure (chi2 trend P = 0.01). CONCLUSIONS: Most SDNVP-exposed women respond well to NNRTI-based therapy but there was an attenuation of therapy efficacy that persisted to 12 months after exposure. Women should be screened for ART eligibility during pregnancy and started on effective regimens before delivery.

Pragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up. We previously showed that an on-site coaching intervention focused on the World Health Organization Safe Childbirth Checklist (SCC) improved performance of essential birth practices (EBPs) in one facility in Karnataka, India. We report on the process and outcomes of adapting the intervention prior to larger-scale implementation in a randomized controlled trial in Uttar Pradesh (UP), India. Initially, we trained a local team of physicians and nurses to coach birth attendants in SCC use at two public facilities for 4–6 weeks. Trained observers evaluated adherence to EBPs before and after coaching. Using mixed methods and a systematic adaptation process, we modified and strengthened the intervention. The modified intervention was implemented in three additional facilities. Pre/post-change in EBP prevalence aggregated across facilities was analyzed. In the first two facilities, limited improvement was seen in EBPs with the exception of post-partum oxytocin. Checklists were used

International worked with Namibia’s Ministry of Health and Social Services to provide comprehensive emergency obstetric and neonatal care (EmONC) and lifesaving skills (LSS) training in four district hospitals in Kavango region (Andara, Nankudu, Nyangana, Rundu). Recognizing that services improve and communities thrive when health workers perform their jobs efficiently and effectively, IntraHealth also used its performance improvement approach to correct outdated practices and enhance and monitor health worker performance. Structure/Method/Design: Performance problems are often complex, with difficult-to-pinpoint origins. IntraHealth’s approach identifies the root causes of performance problems and offers solutions. The approach includes structured interviews, observation, record reviews, and on-site mentorship. The interviews assessed how well health workers in maternity departments were preventing, identifying, and managing obstetric/newborn complications; considered facilities’ provision of essential services based on EmONC signal functions (a shortlist of key lifesaving obstetric interventions); and identified resource and expertise shortages. Observations of health workers during deliveries assessed practices—especially during active management of third stage of labor and immediate newborn care. Record review examined a 20% random sample of deliveries (past two months), focusing on timely, accurate, and complete partograph use and follow-up. When these methods identified problems or gaps, mentoring and coaching led by the ministry’s regional management team and IntraHealth were put into place, including hospital team meetings to identify performance improvements. Outcomes & Evaluation: Three of the four hospitals documented improvements in the quality of maternity care provided. Providing an excellent example of management’s ownership of performance improvement initiatives, one hospital implemented best practices such as regularly reviewing maternity ward records and displaying posters on maternity ward walls to make it easier for staff to find information in emergencies and provide standardized care. In other instances, nurses who attended the EmONC/LSS training identified the need for more support from hospital managers to implement improvements, which became the focus of subsequent site visits. Going Forward: Health workers who receive training require managers’ support to institute new ways of doing things. Regional management teams must provide follow-up to reinforce learning and correct misconceptions. Moreover, because only a few staff can be trained at a time, colleagues should receive in-service training to expose all maternity staff to key EmONC concepts. Obtaining buy-in from managers at the regional/facility levels includes working through contentious issues to obtain support for best practices that may represent a shift from current practices. Funding: United States Agency for International Development. Abstract #: 01ITIS014

HIV and violence are two major public health problems increasingly shown to be connected and relevant to international mental health issues and HIV-related services. Qualitative research is important due to the dearth of literature on this association in developing countries, cultural influences on mental health syndromes and presentations, and the sensitive nature of the topic. The study presented in this paper sought to investigate the mental health issues of an HIV-affected population of women and children in Lusaka, Zambia, through a systematic qualitative study. Two qualitative methods resulted in the identification of three major problems for women: domestic violence (DV), depression-like syndrome, and alcohol abuse; and children: defilement, DV, and behavior problems. DV and sexual abuse were found to be closely linked to HIV and alcohol abuse. This study shows the local perspective of the overlap between violence and HIV. Results are discussed in relation to the need for violence and abuse to be addressed as HIV services are implemented in sub-Saharan Africa.

Background Neonatal hypothermia is increasingly recognized as a risk factor for newborn survival. The World Health Organization recommends maintaining a warm chain and skin-to-skin care for thermoprotection of newborn children. Since little is known about practices related to newborn hypothermia in rural Africa, this study's goal was to characterize relevant practices, attitudes, and beliefs in rural Zambia. Methods and Findings We conducted 14 focus group discussions with mothers and grandmothers and 31 in-depth interviews with community leaders and health officers in Lufwanyama District, a rural area in the Copperbelt Province, Zambia, enrolling a total of 171 participants. We analyzed data using domain analysis. In rural Lufwanyama, community members were aware of the danger of neonatal hypothermia. Caregivers' and health workers' knowledge of thermoprotective practices included birthplace warming, drying and wrapping of the newborn, delayed bathing, and immediate and exclusive breastfeeding. However, this warm chain was not consistently maintained in the first hours postpartum, when newborns are at greatest risk. Skin-to-skin care was not practiced in the study area. Having to assume household and agricultural labor responsibilities in the immediate postnatal period was a challenge for mothers to provide continuous thermal care to their newborns. Conclusions Understanding and addressing community-based practices on hypothermia prevention and management might help improve newborn survival in resource-limited settings. Possible interventions include the implementation of skin-to-skin care in rural areas and the use of appropriate, low-cost newborn warmers to prevent hypothermia and support families in their provision of newborn thermal protection. Training family members to support mothers in the provision of thermoprotection for their newborns could facilitate these practices.

In Vietnam, despite the possibility of living healthy sexual lives and bearing children due to the increasing availability of antiretroviral therapy and prevention of mother-to-child transmission services, HIV programming has given little attention to the sexual and reproductive health of people living with HIV. Our study explored factors influencing sexual and reproductive health decision-making, needs, rights and access to services for women living with HIV in Hai Phong and Ho Chi Minh City. Nearly half of the women were sexually active at the time of the study and 15% reported wanting a child or another child. Only 14% of women who did not want a child used contraceptive services in the last six months. More than 40% of women reported being advised, primarily by health care providers and family members, to abstain from sex, and more than 13% who were pregnant at the time of the study said that they had been advised to have an abortion. As with all women, women living with HIV must be informed of their sexual and reproductive rights and must have access to medically sound counseling and services to facilitate informed reproductive health decision-making. Sexual and reproductive health services are urgently needed for this population.

Importance Based on older analyses, the World Health Organization (WHO) recommends that cesarean delivery rates should not exceed 10 to 15 per 100 live births to optimize maternal and neonatal outcomes. Objectives To estimate the contemporary relationship between national levels of cesarean delivery and maternal and neonatal mortality. Design, Setting, and Participants Cross-sectional, ecological study estimating annual cesarean delivery rates from data collected during 2005 to 2012 for all 194 WHO member states. The year of analysis was 2012. Cesarean delivery rates were available for 54 countries for 2012. For the 118 countries for which 2012 data were not available, the 2012 cesarean delivery rate was imputed from other years. For the 22 countries for which no cesarean rate data were available, the rate was imputed from total health expenditure per capita, fertility rate, life expectancy, percent of urban population, and geographic region. Exposures Cesarean delivery rate. Main Outcomes and Measures The relationship between population-level cesarean delivery rate and maternal mortality ratios (maternal death from pregnancy related causes during pregnancy or up to 42 days postpartum per 100 000 live births) or neonatal mortality rates (neonatal mortality before age 28 days per 1000 live births). Results The estimated number of cesarean deliveries in 2012 was 22.9 million (95% CI, 22.5 million to 23.2 million). At a country-level, cesarean delivery rate estimates up to 19.1 per 100 live births (95% CI, 16.3 to 21.9) and 19.4 per 100 live births (95% CI, 18.6 to 20.3) were inversely correlated with maternal mortality ratio (adjusted slope coefficient, −10.1; 95% CI, −16.8 to −3.4; P = .003) and neonatal mortality rate (adjusted slope coefficient, −0.8; 95% CI, −1.1 to −0.5; P P P = .004). Conclusions and Relevance National cesarean delivery rates of up to approximately 19 per 100 live births were associated with lower maternal or neonatal mortality among WHO member states. Previously recommended national target rates for cesarean deliveries may be too low.

Background Breast milk transmission of HIV-1 remains a major route of pediatric infection. Defining the characteristics of viral variants to which breastfeeding infants are exposed is important for understanding the genetic bottleneck that occurs in the majority of mother-to-child transmissions. The blood-milk epithelial barrier markedly restricts the quantity of HIV-1 in breast milk, even in the absence of antiretroviral drugs. The basis of this restriction and the genetic relationship between breast milk and blood variants are not well established. Methodology/Principal Findings We compared 356 HIV-1 subtype C gp160 envelope (env) gene sequences from the plasma and breast milk of 13 breastfeeding women. A trend towards lower viral population diversity and divergence in breast milk was observed, potentially indicative of clonal expansion within the breast. No differences in potential N-linked glycosylation site numbers or in gp160 variable loop amino acid lengths were identified. Genetic compartmentalization was evident in only one out of six subjects in whom contemporaneously obtained samples were studied. However, in samples that were collected 10 or more days apart, six of seven subjects were classified as having compartmentalized viral populations, highlighting the necessity of contemporaneous sampling for genetic compartmentalization studies. We found evidence of CXCR4 co-receptor using viruses in breast milk and blood in nine out of the thirteen subjects, but no evidence of preferential localization of these variants in either tissue. Conclusions/Significance Despite marked restriction of HIV-1 quantities in milk, our data indicate intermixing of virus between blood and breast milk. Thus, we found no evidence that a restriction in viral genotype diversity in breast milk accounts for the genetic bottleneck observed following transmission. In addition, our results highlight the rapidity of HIV-1 env evolution and the importance of sample timing in analyses of gene flow.

Objective. To improve care of sexually abused children by establishment of a “One Stop Centre” at the University Teaching Hospital.Methodology. Prior to opening of the One Stop Centre, a management team comprising of clinical departmental heads and a technical group of professionals (health workers, police, psychosocial counselors lawyers and media) were put in place. The team evaluated and identified gaps and weaknesses on the management of sexually abused children prevailing in Zambia. A manual was produced which would be used to train all professionals manning a One Stop Centre. A team of consultants from abroad were identified to offer need based training activities and a database was developed.Results. A multidisciplinary team comprising of health workers, police and psychosocial counselors now man the centre. The centre is assisted by lawyers as and when required. UTH is offering training to other areas of the country to establish similar services by using a Trainer of Trainers model. A comprehensive database has been established for Lusaka province.Conclusion. For establishment of a One Stop Centre, there needs to be a core group comprising of managers as well as a technical team committed to the management and protection of sexually abused children.

BACKGROUND:We previously reported no benefit of early weaning for HIV-free survival of children born to HIV-infected mothers in intent-to-treat analyses. Since early weaning was poorly accepted, we conducted a secondary analysis to investigate whether beneficial effects may have been hidden. METHODS:958 HIV-infected women in Lusaka, Zambia, were randomized to abrupt weaning at 4 months (intervention) or to continued breastfeeding (control). Children were followed to 24 months with regular HIV PCR tests and examinations to determine HIV infection or death. Detailed behavioral data were collected on when all breastfeeding ended. Most participants were recruited before antiretroviral treatment (ART) became available. We compared outcomes among mother-child pairs who weaned earlier or later than intended by study design adjusting for potential confounders. RESULTS:Of infants alive, uninfected and still breastfeeding at 4 months in the intervention group, 16.1% who weaned as instructed acquired HIV or died by 24 months compared to 16.0% who did not comply (p = 0.98). Children of women with less severe disease during pregnancy (not eligible for ART) had worse outcomes if their mothers weaned as instructed (RH = 2.60 95% CI: 1.06-6.36) compared to those who continued breastfeeding. Conversely, children of mothers with more severe disease (eligible for ART but did not receive it) who weaned early had better outcomes (p-value interaction = 0.002). In the control group, weaning before 15 months was associated with 3.94-fold (95% CI: 1.65-9.39) increase in HIV infection or death among infants of mothers with less severe disease. CONCLUSION:Incomplete adherence did not mask a benefit of early weaning. On the contrary, for women with less severe disease, early weaning was harmful and continued breastfeeding resulted in better outcomes. For women with more advanced disease, ART should be given during pregnancy for maternal health and to reduce transmission, including through breastfeeding. TRIAL REGISTRATION:(ClinicalTrials.gov) NCT00310726.

Sub-Saharan Africa contains over 60% of the world's HIV infections and Zambia is among the most severely affected countries in the region. As antiretroviral programs have been rapidly expanding, the long-term success of these programs depends on a good understanding of the behavioral determinants of acceptance and adherence to antiretroviral therapy (ART). The study used qualitative methods to gain local insight into potentially important factors affecting HIV-infected women's decision to accept or continue with ART. Some of the barriers identified by this study are consistent with factors cited in the existing adherence literature from both developed and developing nations such as side effects, hunger and stigma; other factors have not been previously reported. One major theme was unfamiliarity with the implications of having a chronic, potentially deadly disease. Other emerging themes from this study include the complicated effect of ART on interpersonal relationship, particularly between husbands and wives, the presence of depression and hopelessness, and lack of accurate information. The results suggest that the reasons for non-uptake of treatment include issues related to local cultural frameworks (e.g., illness ideology), mental and behavioral health (e.g., depression and/or interpersonal challenges), stigma, and motivating factors (e.g., values of church or marriage) of different cultures that affect the ability and willingness to take life-saving medicine for a long period of time. Qualitative studies are critical to better understand why ART eligible individuals are choosing not to initiate or continue treatment to achieve needed adherence levels.

The objective was to investigate if breast milk interleukin [IL]-7 concentrations are associated with postnatal HIV transmission. A case-control study nested within a cohort of women recruited in Lusaka Zambia. IL-7 breast milk concentrations were measured in samples from 24 HIV-infected breast-feeding women who transmitted HIV to their child after the neonatal period and from 47 women who did not transmit. Samples were frequency-matched by the time of sample collection (1 week and 1 month postpartum). Logistic regression was used to adjust for possible confounders. For comparison samples from 18 HIV-uninfected women from the same community were included in the analysis and plasma IL-7 was determined. Breast milk IL-7 concentrations were significantly higher than plasma IL-7 concentrations in all 3 groups. In contrast to levels among transmitters and HIV-uninfected women breast milk IL-7 concentrations exhibited a bimodal distribution among nontransmitters. Breast milk IL-7 concentrations undetectable or less than 30 pg/mL were significantly associated with less HIV transmission (odds ratio = 0.13 95% confidence interval: 0.03 to 0.64). The association remained strong after adjustment for breast milk viral load and sodium maternal CD4 cell counts parity and time of sample collection Breast milk IL-7 may be necessary for effective HIV transmission. (authors)

Adequate adherence is required for prevention of mother-to-child transmission of HIV (pMTCT) programs to be effective. We investigated predictors and extent of nonadherence to singledose nevirapine. Data on nevirapine intake and possible predictors were collected among 760 HIV-positive women with liveborn babies enrolled in a study in Lusaka Zambia. Most (94%) women took nevirapine before delivery and most (91%) newborns received it soon after delivery. Maternal nonadherence was associated with home births (odds ratio [OR]: 3.2; 95% confidence interval [CI]: 1.3 to 7.4) no high school education (OR: 2.4; 95% CI: 1.1 to 5.3) and low newborn birth weight (OR: 4.6; 95% CI: 1.3 to 20.1). Disclosure of HIV status and couples counseling was only associated with adherence among home births. Failure to administer nevirapine to the newborn was associated with birth at the tertiary hospital (OR: 7.2; 95% CI: 3.7 to 13.8) lower 5-minute Apgar scores (OR: 0.5; 95% CI: 0.4 to 0.7) and neonatal death (OR: 5.8; 95% CI: 2.0 to 16.3). Excellent adherence to single-dose nevirapine for pMTCT can be achieved. Nonadherence seems to be affected by place of birth and by poor health status of the newborn. Procedures to ensure that viable yet ill neonates receive nevirapine should be part of clinical protocols and training within pMTCT programs. (authors)

A previously reported association between prolonged lactation and maternal mortality has generated concern that breast-feeding may be detrimental for HIV-positive women. As part of a trial conducted in Lusaka Zambia 653 HIV-positive women were randomly assigned either to a counseling program that encouraged abrupt cessation of breast-feeding at 4 months (group A) or to a program that encouraged prolonged breast-feeding for the duration of the woman’s own informed choice (group B). We examined whether mortality up to 2 years post-partum increased with breastfeeding for a longer duration. There was no difference in mortality 12 months after delivery between 326 HIV-positive women randomly assigned to short breast-feeding [group A: 4.93%; 95% confidence interval (CI) 2.42–7.46] versus 327 women assigned to long breast-feeding (group B: 4.89%; 95% CI 2.38–7.40). Analysis based on actual practice rather than random assignment also demonstrated no increased mortality due to breast-feeding. Although HIV-related mortality was high in this cohort of untreated HIV positive women prolonged lactation was not associated with increased mortality. (authors)

Infants born to HIV-infected mothers are at risk of acquiring HIV infection. The risk is serious, but it can be substantially reduced with antiretroviral drugs [1–3]. Yet, even in the absence of interventions, the majority of infants born to HIV-infected mothers do not acquire infection. However, these infants risk losing their mother (and father) to HIV infection during childhood, with the social dislocation of orphanhood posing obvious dangers to their well-being [4–6]. But do HIV-uninfected children have other risks associated with having an HIV-infected mother? There is surprisingly little known about morbidity and mortality among HIV-exposed, HIV-uninfected infants. Demographic studies estimate that mortality among children born to HIV-infected mothers is higher than that among children born to mothers without HIV infection, but interpretation is limited because the proportion of HIV-infected children is not known [6–9]. Factors affecting morbidity and mortality in general (e.g., lack of breastfeeding, unhygienic living conditions, and malaria exposure) are also likely to be important among HIV–exposed, HIV-uninfected infants. In addition, HIV exposure directly or indirectly in utero, intrapartum, and during breastfeeding may confer risks to infants, even in the absence of vertical transmission. Perinatal transmission and disease progression among infected infants are higher among those born to mothers with more advanced HIV disease [10–12]. The effect, if any, on uninfected offspring is unclear. Here, we investigate whether advanced HIV disease and/or immune dysfunction among HIV-infected mothers increases mortality and morbidity among their uninfected infants. Any effect will have substantial public health consequences, because the absolute number of reproductive-aged women with HIV infection continues to increase.

Background Empirical data showing the clear benefits of exclusive breastfeeding (EBF) for HIV prevention are needed to encourage implementation of lactation support programs for HIV-infected women in low resource settings among whom replacement feeding is unsafe. We conducted a prospective, observational study in Lusaka, Zambia, to test the hypothesis that EBF is associated with a lower risk of postnatal HIV transmission than non-EBF. Methods and Results As part of a randomized trial of early weaning, 958 HIV-infected women and their infants were recruited and all were encouraged to breastfeed exclusively to 4 months. Single-dose nevirapine was provided to prevent transmission. Regular samples were collected from infants to 24 months of age and tested by PCR. Detailed measurements of actual feeding behaviors were collected to examine, in an observational analysis, associations between feeding practices and postnatal HIV transmission. Uptake of EBF was high with 84% of women reporting only EBF cumulatively to 4 months. Post-natal HIV transmission before 4 months was significantly lower (p = 0.004) among EBF (0.040 95% CI: 0.024–0.055) than non-EBF infants (0.102 95% CI: 0.047–0.157); time-dependent Relative Hazard (RH) of transmission due to non-EBF = 3.48 (95% CI: 1.71–7.08). There were no significant differences in the severity of disease between EBF and non-EBF mothers and the association remained significant (RH = 2.68 95% CI: 1.28–5.62) after adjusting for maternal CD4 count, plasma viral load, syphilis screening results and low birth weight. Conclusions Non-EBF more than doubles the risk of early postnatal HIV transmission. Programs to support EBF should be expanded universally in low resource settings. EBF is an affordable, feasible, acceptable, safe and sustainable practice that also reduces HIV transmission providing HIV-infected women with a means to protect their children's lives. Trial Registration ClinicalTrials.gov NCT00310726

Background Single-dose nevirapine (SDNVP) for the prevention of mother-to-child HIV transmission (PMTCT) results in the selection of resistance mutants among HIV-infected mothers. The effects of these mutations on the efficacy of SDNVP use in a subsequent pregnancy are not well understood. Methods We compared risks of perinatal HIV transmission between multiparous women who had previously received a dose of SDNVP (exposed) and those that had not (unexposed) and who were given SDNVP for the index pregnancy within a PMTCT clinical study. We also compared transmission risks among exposed and unexposed women who had two consecutive pregnancies within the trial. Logistic regression modeling was used to adjust for possible confounders. Results Transmission risks did not differ between 59 SDNVP-exposed and 782 unexposed women in unadjusted analysis or after adjustment for viral load and disease stage (adjusted odds ratio 0.6, 95% confidence interval [CI] 0.2 to 2.0). Among 43 women who had two consecutive pregnancies during the study, transmission risks were 7% (95% CI 1% to 19%) at both the first (unexposed) and second (exposed) delivery. The results were unchanged, if infant death was included as an outcome. Conclusion These data suggest that the efficacy of SDNVP may not be diminished when reused in subsequent pregnancies.

Background Teaming is an accepted approach in health care settings but rarely practiced at the community level in developing countries. Save the Children trained and deployed teams of volunteer community health workers (CHWs) and trained traditional birth attendants (TBAs) to provide essential newborn and curative care for children aged 0–59 months in rural Zambia. This paper assessed whether CHWs and trained TBAs can work as teams to deliver interventions and ensure a continuum of care for all children under-five, including newborns. Methods We trained CHW-TBA teams in teaming concepts and assessed their level of teaming prospectively every six months for two years. The overall score was a function of both teamwork and taskwork. We also assessed personal, community and service factors likely to influence the level of teaming. Results We created forty-seven teams of predominantly younger, male CHWs and older, female trained TBAs. After two years of deployment, twenty-one teams scored “high”, twelve scored “low,” and fourteen were inactive. Teamwork was high for mutual trust, team cohesion, comprehension of team goals and objectives, and communication, but not for decision making/planning. Taskwork was high for joint behavior change communication and outreach services with local health workers, but not for intra-team referral. Teams with members residing within one hour’s walking distance were more likely to score high. Conclusion It is feasible for a CHW and a trained TBA to work as a team. This may be an approach to provide a continuum of care for children under-five including newborns.